Faults on pharmaceutical production lines can be broadly classified into four categories: mechanical, electrical, process‑related, and software‑related. There are also fault scenarios specific to particular production line segments. Each category has clear diagnostic and resolution methods.
1. Common Mechanical Faults and Troubleshooting
Component wear and fatigue fracture – Prolonged friction and impact during operation can cause bearing wear, gear breakage, agitator shaft deformation, etc. Daily preventive measures include regular equipment spot checks, scheduled lubrication, and replacement of wear parts. When a fault occurs, simply replace the damaged components to restore normal operation.
Poor lubrication and overheating – Lubrication system failures or insufficient lubricant can lead to excessive heating or seizing. Regularly inspect the lubrication system status and promptly replenish or replace lubricant with the correct grade.
Abnormal vibration and noise – Imbalance, insufficient assembly precision, or loose parts can cause abnormal vibration and noise. Check the levelness of equipment installation, readjust assembly accuracy, and tighten all loose fasteners.
Conveyor belt slack – This affects material transfer efficiency. The problem can be solved by adjusting the belt tension.
Valve seal failure – This results in media leakage. Analyze the cause by observing leak traces and pressure changes, and replace the seals or tighten connecting bolts as appropriate.
Faults in dedicated working components – For example, hammer wear in crushers, blade deformation in mixers, or scraper plate detachment in dryers directly affect production efficiency and product quality. Replace the worn components or optimise the structural design to improve durability.
2. Common Electrical Faults and Troubleshooting
Power supply anomalies – Voltage instability, overcurrent/undercurrent, or frequency deviations affect equipment operation. Install voltage regulation devices to ensure stable power supply, and inspect for short circuits, poor contacts, etc.
Control circuit faults – Aging components, shorts, or open circuits lead to control function failure. Use PLC logs, circuit diagrams, and on‑site testing to progressively narrow down the fault range, and replace aged or damaged components.
Sensor and actuator faults – Incorrect sensor data or actuator malfunction interferes with normal operation. Regularly clean sensors and calibrate their ranges; choose dust‑proof and corrosion‑resistant types. For actuator faults, check connecting wires and drive parts, then repair or replace as needed.
Motor faults – Common issues include overload, short circuits, and insulation aging. Monitor current, voltage, and insulation resistance for early warning. Abnormal sounds, odours, or vibration during motor operation are also important indicators. Repair or replace the motor promptly when faults occur.
3. Common Process‑Related Faults and Troubleshooting
Abnormal process parameters – Temperature, pressure, flow, etc., deviating from set ranges lead to unstable product quality. Re‑calibrate relevant sensors, introduce online monitoring systems to maintain parameter stability, and adjust equipment operating parameters according to material characteristics.
Drug contamination and cross‑contamination – Inadequate equipment cleaning or improper segregation measures can cause contamination and cross‑contamination risks. Strengthen cleaning procedures, improve segregation and protective measures, and perform regular cleaning validation on equipment.
Inappropriate equipment configuration – Design flaws or incorrect initial selection can hinder process flow and reduce efficiency. Conduct a comprehensive assessment of existing equipment and, if necessary, upgrade or replace equipment.
4. Common Software‑Related Faults and Troubleshooting
System crashes and freezes – Usually caused by software bugs, virus attacks, or memory overflow. Resolve by updating software to fix bugs, installing antivirus software, and increasing memory to prevent overflow, thereby restoring system operation.
5. Fault Scenarios in Specific Production Line Segments (e.g., Automatic Oral Liquid Filling and Labeling Line)
Filling accuracy deviation – Manifested as inconsistent fill volumes exceeding the allowable tolerance. Calibrate filling precision before daily start‑up; after operation, flush filling nozzles and pipelines with a dedicated cleaning solution to remove residual material. Also adjust filling speed and suck‑back volume according to the viscosity of the oral liquid.
Leakage and liquid hanging (droplet adhesion) – Leakage is often due to aged seals or poor nozzle‑bottle compatibility; liquid hanging is usually caused by excessive filling speed or high material viscosity. Regularly inspect and replace aged seals, select nozzles that match the bottle type, incorporate a negative‑pressure suck‑back device to reduce hanging, and appropriately reduce filling speed.
Labeling issues – Problems such as skewed labels, bubbles, or missed labels often arise from sensor position drift, poor label quality, or improper conveyor belt tension. Re‑calibrate sensor positions, adjust belt tension, use standard‑compliant labels, adjust scraper brush force and angle to eliminate skew and bubbles, and inspect the label detection photoelectric device to avoid missed labels.
Equipment jamming – Usually related to poor electrical contact or insufficient lubrication of moving parts. Routinely clean control system dust, check wiring tightness, and regularly add lubricant to transmission components.
